Clinical trial · Interventional
A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms, Castration-Resistant | Prostate Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Arm 1A: Docetaxel + BMS-986218
- interventionNames
- Biological: BMS-986218
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Arm 1B: Docetaxel + BMS-986218 + Nivolumab
- interventionNames
- Biological: BMS-986218
- Drug: Docetaxel
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Arm 2A: Docetaxel
- interventionNames
- Drug: Docetaxel
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic confirmation of carcinoma of the prostate without small cell features * Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate * Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI) * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit * Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT) Exclusion Criteria: * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2 * Untreated central nervous system (CNS) metastases * Leptomeningeal metastases * Active, known or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available